NCT04394182

Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fundacion GenesisCare · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose \< 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

Detailed description

The exceedingly high mortality rates of severe and critical COVID-19 warrant the evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. In this context, is proposes a prospective multicenter study. It will include 15 patients, to assess the feasibility and efficacy of low-dose lung irradiation in COVID-19 pneumonia.

Conditions

• Pneumonia, Viral
• Cytokine Storm

Interventions

Type	Name	Description
RADIATION	Ultra-Low-dose radiotherapy	The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.
DEVICE	ventilatory support with oxygen therapy	Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
DRUG	Lopinavir/ritonavir	100/400 mg/12h; 7-10 days
DRUG	Hydroxychloroquine	200 mg/12h
DRUG	Azithromycin	500 mg/24h, 3 days
DRUG	Piperacillin/tazobactam	4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function
DRUG	Low molecular weight heparin	prophylactic doses
DRUG	Corticosteroid injection	250mg x 3 boluses
DRUG	Tocilizumab	600mg single dose

Timeline

• Start date: 2020-04-21
• Primary completion: 2020-12-31
• Completion: 2022-03-21
• First posted: 2020-05-19
• Last updated: 2022-03-29

Locations

2 sites across 1 country: Spain